XPERT20

GUDID B619X20Q9

specimen x-ray system

Kubtec

Tissue specimen x-ray system IVD
Primary Device IDB619X20Q9
NIH Device Record Key423c8b2b-16e5-4058-945f-4a78ea944980
Commercial Distribution StatusIn Commercial Distribution
Brand NameXPERT20
Version Model NumberXPERT 20
Company DUNS361955128
Company NameKubtec
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com
Phone2033648544
Emailapangaio@kubtec.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB619X20Q9 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-03
Device Publish Date2025-03-26

Devices Manufactured by Kubtec

B619K0018C01UP0 - GammaPro Straight Standard Probe2025-04-03 GammaPro Straight Standard Probe for wireless ionizing radiation detection.
B619K0019C01UW0 - GammaPro High Sensitivity Probe2025-04-03 GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
B619K0020C01TA0 - GammaPro Laparoscopic Probe2025-04-03 GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
B619K0021C01TH0 - GammaPro Angled Standard Probe2025-04-03 GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
B619X20Q9 - XPERT202025-04-03specimen x-ray system
B619X20Q9 - XPERT202025-04-03 specimen x-ray system
B619X40QF0 - XPERT402025-04-03 Specimen x-ray system
B619X42QK0 - XPERT422025-04-03 Specimen x-ray system
B619X80LAR0 - XPERT80L2025-04-03 Specimen x-ray system

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